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Guidance on Naming Biological Products

08/28/2015

Federal Register Notice: FDA is making available a draft guidance for industry entitled Nonproprietary Naming of Biological Products. The draft guidance describes the agency’s current thinking on the need for biological products licensed under the Public Health Service Act to bear a nonproprietary name that includes an FDA-designated suffix. To download this guidance, click here. To view this notice, click here.

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